FDA approves AIDS drug

Published: 10:12AM Saturday July 09, 2005 Source: Reuters

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A generic version of GlaxoSmithKline Plc's combination AIDS drug Combivir won tentative US approval on Friday for use under US President George W. Bush's global AIDS relief plan.
   
The drug, made by India's Aurobindo Pharma's, is a nucleoside reverse transcriptase inhibitor that helps suppress HIV, the virus that causes AIDS.
   
Health and Human Services Secretary Mike Leavitt said that drug, known chemically as lamivudine and zidovudine, was the first combination drug approved for the President's Emergency Plan for AIDS Relief (PEPFAR).
   
"This product is a critical part of the arsenal in the global fight against HIV/AIDS," Leavitt said in a statement.
   
The five-year, US$15 billion program launched in 2003 aims to pay for treatment for 2 million AIDS sufferers and provide care for 10 million others.
   
The tentative approval means the generic drug meets the FDA's safety and efficacy standards, but cannot be sold in the United States because of patent or exclusivity constraints.
   
Aurobindo Pharma, based in Ameerpet, Sanjeeva, India, has had several other AIDS drugs approved for Bush's program.

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